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Torcon NB G08895Recalls & reported problems

Cook Incorporated · Torcon NB, Advantage Catheter · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002088955), received between Jun 1, 2020 and Sep 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Oct 21, 2019Terminated

    The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

    Z-0455-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Contamination /Decontamination Problem1
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 9, 2021Material Separation; Material Separation

    AS REPORTED, DURING AN UNSPECIFIED ARTERIAL PROCEDURE IN THE THORACIC REGION, THE END OF A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER SEPARATED IN THE PATIENT. THE SEPARATED FRAGMENT WAS SNARED FROM THE PATIENT, WHO IS REPORTEDLY RECOVERING WELL. THE PROCEDURE WAS PROLONGED, AND THE PATIENT WAS EXPOSED TO ADDITIONAL RADIATION DURING RETRIEVAL OF THE DEVICE, DURING WHICH MULTIPLE CATHETER EXCHANGES AND MANIPULATIONS WERE PERFORMED; HOWEVER, THERE HAS BEEN NO REPORT THAT THE PATIENT EXPERIENCED ANY HARM AS A RESULT. NORMAL TORTUOSITY OF THE ARCH VESSELS WAS NOTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12445820 ↗
  • MalfunctionJun 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Patient Involvement

    MAUDE report 10105508 ↗

Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices

All CATHETER, INTRAVASCULAR, DIAGNOSTIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.